CMS Issues Proposed Rules for the Medicare Program; Transitional Coverage for Emerging Technologies (TCET)

On June 27, 2023, the Centers for Medicare and Medicaid Services (CMS) issued the proposed rule for the Medicare Program; Transitional Coverage for Emerging Technologies (TCET).

CMS is proposing to provide transitional coverage for emerging technologies (TCET) through the national coverage determination (NCD) process. This pathway is intended to provide more transparency, predictability, and expedited national coverage for eligible Breakthrough Devices, authorized by the Food and Drug Administration (FDA); and continue through procedural notice rather than rulemaking process as another way to expedite the process.

The TECT pathway proposal is intended to assist CMS when making coverage decisions through the following considerations:

  1. Facilitate early, predictable and safe beneficiary access to new technologies;
  2. Reduce uncertainty regarding coverage by early evaluation of the potential benefits and harms of technologies with innovators; and
  3. Encourage evidence development if notable evidence gaps exist for coverage purposes.

The Breakthrough Devices Program will have 2 levels of criterion that must be met in order to be eligible for the TCET pathway:

  1. The device provides for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions.
  2. The device must satisfy one of the following elements:
    • It represents a breakthrough technology;
    • No approved or cleared alternatives exist;
    • It offers significant advantages over existing approved or cleared alternatives, including the potential roved or cleared alternatives, including the potential, compared to existing approved alternatives, to reduce or eliminate the need for hospitalization, improve patient quality of life, facilitate patients’ ability to manage their own care (such as through self-directed personal assistance), or establish long-term clinical efficiencies;
    • Device availability is in the best interest of patients.

There are 3 stages of the proposed TCET pathway: 1) premarket, 2) coverage under TCET pathway, and 3) transition to post-TCET coverage. TCET pathway limits who may be eligible, and CMS indicated there are other expedited options for coverage that may be available to those who do not qualify, namely a Parallel Review, will continue to be an option.  CMS will work with the FDA to discuss potential updates to the current Parallel Review process between the two entities for greater efficiency and simplicity of coverage considerations for non-Breakthrough Devices.

The complete TECT proposed rule summary can be found on the GORE Coding Resource Center website under “Education – CMS Rules Updates”: https://gore.rccsclients.com/education/rules-updates/.